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Pharmaceutical News and Articles

Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Jan. 12, 2018

Posted 4 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Wild Monkeys in Florida Could Pass Herpes to People Some non-native monkeys in Florida carry herpes B, a virus that can be dangerous to people, a new study says. Researchers found that some rhesus macaques in Silver Springs State Park have the virus in their saliva and other bodily fluids and could spread the...

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Hold That Sneeze? Maybe Not

Posted today in Medical

TUESDAY, Jan. 16, 2018 -- Holding your nose and closing your mouth when you feel a sneeze coming on just might lead to serious trouble. The journal BMJ Case Reports includes the story of a 34-year-old man who ruptured his throat after he pinched his nose and clamped his mouth shut in order to ward off a sneeze. He suffered significant pain and was barely able to speak or swallow. Spontaneous rupture of the back of...

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Sauna Sessions May Be as Good as Exercise for the Heart

Posted today in Medical

TUESDAY, Jan. 16, 2018 -- Relaxing in a hot sauna may not only feel good -- it might affect your heart and blood vessels in ways that are similar to moderate exercise. That's the finding of a new study that tested the effects of a 30-minute sauna session. The researchers say their results may help explain why people who regularly use saunas tend to have a decreased risk for heart disease and even dementia. On...

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Early Periods, Higher Heart Risks?

Posted today in Medical

TUESDAY, Jan. 16, 2018 -- Women whose periods started before age 12 may face an increased risk for heart disease and stroke, a new British study suggests. Early menopause, pregnancy complications and hysterectomy are also associated with a higher risk for heart disease and stroke, according to the research. "More frequent cardiovascular screening would seem to be sensible among women who are early in their...

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Workplace Workouts … and Why They Work

Posted today in Medical

TUESDAY, Jan. 16, 2018 -- Workplace wellness programs are great ways to get in shape, but what if your employer doesn't offer one? Here's how to get the (exercise) ball rolling. First, talk to your human resources manager and make the case for wellness initiatives with physical activity components. Highlight the U.S. government's exercise guidelines for adults -- to get 150 minutes of cardio per week -- and the...

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FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer

Posted 3 days ago in New Drug Approvals

January 12, 2018 -- The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug...

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FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma

Posted 11 days ago in New Drug Approvals

THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The...

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Monthly News Roundup - December 2017

Posted 2 weeks ago in Pharma Industry News

Luxturna Gene Therapy OK’d for Rare Form of Vision Loss A historic approval, Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics is the first directly administered gene therapy that targets a disease caused by specific gene mutations. In December the U.S. Food and Drug Administration (FDA) approved Luxturna, used in patients with biallelic RPE65-mediated inherited retinal disease (IRD), a form of v...

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Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma

Posted 2 weeks ago in New Drug Applications

NEW YORK, Dec. 29, 2017 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Azedra® in patients with malignant, recurrent and/or unresectable pheochromocytoma and ...

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FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers

Posted 2 weeks ago in Pharma Industry News

Today, the Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the...

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GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome

Posted 2 weeks ago in New Drug Applications

LONDON and CARLSBAD, Calif., Dec. 28, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) ("GW" or "the Company"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug...

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TherapeuticsMD Announces Submission of New Drug Application for TX-001HR

Posted 2 weeks ago in New Drug Applications

BOCA RATON, Fla.--(BUSINESS WIRE)--Dec. 28, 2017-- TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, announced today that it has submitted the New Drug Application (NDA) for TX-001HR, the company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause, wit...

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Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation

Posted 3 weeks ago in New Drug Applications

CAMBRIDGE, Mass., Dec. 26, 2017 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ivosidenib (AG-120), an investigational oral treatment for patients with relapsed or refractory acute myeloid leukemia...

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Bausch + Lomb Receives FDA Approval of Lumify (brimonidine tartrate) Over-the-Counter Eye Drop for the Treatment of Eye Redness

Posted 3 weeks ago in New Drug Approvals

LAVAL, Quebec, Dec. 22, 2017 /PRNewswire/ -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant"), today announced that the U.S. Food and Drug Administration (FDA) has approved Lumify (brimonidine tartrate ophthalmic solution 0.025%) as the first and only over-the-counter (OTC) eye drop developed with...

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FDA Approves Segluromet (ertugliflozin and metformin hydrochloride) for Type 2 Diabetes

Posted 3 weeks ago in New Drug Approvals

KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE) December 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved Segluromet (ertugliflozin and metformin hydrochloride) tablets. Ertugliflozin is a newly approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Segluromet is...

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FDA Approves Steglujan (ertugliflozin and sitagliptin) for Type 2 Diabetes

Posted 3 weeks ago in New Drug Approvals

KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE) December 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved Steglujan (ertugliflozin and sitagliptin) tablets. Ertugliflozin is a newly approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Steglujan is indicated as an...

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FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer

Posted 3 weeks ago in Pharma Industry News

December 22, 2017 -- Today, the U.S. Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With today’s clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue,” said Robert Ochs, Ph.D., acting deputy direc...

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Agile Therapeutics, Inc. Receives a Complete Response Letter from the FDA for Twirla (AG200-15) for the Prevention of Pregnancy

Posted 3 weeks ago in New Drug Applications

PRINCETON, N.J., Dec. 22, 2017 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (NASDAQ:AGRX), a women's healthcare company, today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) in response to the New Drug Application (NDA) resubmission for the Company's investigational non-daily, low dose combination hormonal contraceptive patch, Twirla (AG200-15). The resubmission...

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FDA Proposes New, Risk-Based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs

Posted 4 weeks ago in Pharma Industry News

Today, the Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to o...

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FDA Launches New Tool for Sharing Information That Allows Doctors to Better Manage Antibiotic Use

Posted 4 weeks ago in Pharma Industry News

Today the Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is...

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AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis

Posted 8 days ago in Clinical Trials

NORTH CHICAGO, Ill., Jan. 8, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic...

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Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients

Posted 12 days ago in Clinical Trials

Cambridge, Mass. – January 4, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for maribavir (SHP620), a Phase 3 investigational treatment for cytomegalovirus (CMV) infection and disease in transplant patients resistant or refractory to prior therapy. By targeting a...

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FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response

Posted 3 weeks ago in Clinical Trials

December 22, 2017 -- The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). With today’s updated dosing r...

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Rhizen Pharmaceuticals S.A. Receives FDA Orphan-Drug Designation for Tenalisib (RP6530) for Treatment of Peripheral T-Cell Lymphoma (PTCL)

Posted 3 weeks ago in Clinical Trials

La Chaux-de-Fonds, Switzerland, Dec. 22, 2017 (GLOBE NEWSWIRE) -- Rhizen Pharmaceuticals S.A., today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the active moiety of Tenalisib (RP6530), the Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, for treatment of peripheral T-cell lymphoma (PTCL). “We are pleased to receive US FDA orp...

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AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints

Posted 3 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing study evaluated upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis...

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